Pediatric ECMO Oxygenator with Integrated Monitoring

带集成监控功能的儿科 ECMO 氧合机

• 批准号: 10320808
• 负责人: Scott I Merz
• 金额: $ 88.64万
• 依托单位: MC3, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-23 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10320808
• 关键词: Address; Adhesions; Adult; Area; Blood; Blood flow; Cardiopulmonary; Childhood; Clinical; Coagulation Process; Development; Devices; Diagnostic; Engineering; Equilibrium; European; Extracorporeal Membrane Oxygenation; Failure; Freezing; Funding; Future; Gases; Goals; Hemolysis; Hemorrhage; Hemostatic Agents; Hour; In Vitro; Lung; Manufacturer Name; Measures; Medical Device; Monitor; Morbidity - disease rate; Neonatal; Oxygenators; Pathway interactions; Patients; Pediatrics; Performance; Phase; Platelet Activation; Population; Positioning Attribute; Price; Regulation; Resistance; Risk; Site; System; Technology; Testing; Thrombosis; Time; United States National Institutes of Health; Work; aged; base; biomaterial compatibility; cost; design; experience; in vivo; innovation; manufacturing process; mortality; neonatal patient; novel; off-label use; pediatric patients; platelet function; platelet preservation; prevent; prototype; research and development; sensor; sensor technology; success; thrombogenesis; thrombotic complications; verification and validation

ABSTRACT Extracorporeal membrane oxygenation (ECMO) is increasingly utilized to provide cardiopulmonary support in patients due to its versatility, immediate benefit, and relatively low cost. However, there continues to be significant morbidity and mortality related to hemostatic complications, especially in the neonatal and pediatric population. A few pediatric oxygenators are used in ECMO; however, all of these devices only have short term approval and are currently used off label in ECMO. In addition, a variety of monitors are needed in an ECMO circuit, which add to the complexity of the workflow and introduce access sites that can disrupt the blood flow path. Currently, there is no such oxygenator approved for long term use in pediatrics. The goal of this project is to develop a pediatric ECMO oxygenator with integrated sensors that is optimized for long term use in pediatric ECMO. In Phase I, the MC3 Ped-ECMO Oxygenator (PedOxy) was designed specifically with an optimized flow path that minimizes clotting by avoiding areas of high shear as well as stagnant zones. A non-heparin coating, Balance Biosurface, has been selected to prevent thrombosis and preserve platelet function. In addition, a simplified monitoring system was integrated into the disposable oxygenator that will provide real-time diagnostics, minimize blood path disruptions and simplify workflows. The manufacturing processes for creating the unique flow path was advanced. Prototypes of the PedOxy were demonstrated to match competitors’ gas exchange while showing superior clotting performance in vitro. With Phase II funding, the MC3 PedOxy will reach design freeze, verification/validation testing will be completed, and the design will be transferred to in-house MC3 manufacturing. Pilot in vivo studies will be performed to prepare for the GLP study that is required for regulatory submissions for the ECMO pathway in the US and CE Mark in accordance with the new European Medical Device Regulation. We have assembled a team of experts, clinicians, marketers, manufacturers and engineers who are uniquely qualified to carry out the proposed work.

抽象的 体外膜氧合（ECMO）越来越多地用于提供心肺支持 由于患者的多功能性，直接收益和相对较低的成本。但是，仍然有 与止血并发症有关的显着发病率和死亡率，尤其是在新生儿和小儿中 人口。 ECMO中使用了一些小儿氧合；但是，所有这些设备只有短期 批准，目前已在ECMO中使用。此外，在ECMO中需要各种监视器 电路，这增加了工作流程的复杂性并引入可能破坏血液流动的访问站点 小路。目前，尚未批准这种氧合剂用于儿科。 该项目的目的是开发带有集成传感器的儿科ECMO氧合器 优化用于长期用于小儿ECMO。在第一阶段，MC3 PED-ECMO氧合（Pedoxy）为 专门通过优化的流动路径设计，该路径也通过避免高剪切的区域来最大程度地减少衣服 作为停滞的区域。已经选择了非黄瓜蛋白涂层，平衡生物表面，以防止血栓形成和 保留血小板功能。此外，简化的监视系统已集成到处置中 充氧剂将提供实时诊断，最大程度地减少血液路径中断并简化工作流程。 为创建独特流动路径的制造过程是先进的。 Pedoxy的原型是 证明可以匹配竞争对手的气体交换，同时显示出出色的服装性能 体外。 通过II期资金，MC3 Pedoxy将达到设计冻结，验证/验证测试将是 完成，设计将转移到内部MC3制造。体内研究将是 为了准备GLP研究的准备，这是ECMO途径的监管提交所需的 美国和CE商标按照新的欧洲医疗设备法规。我们已经组装了 专家，临床医生，营销人员，制造商和工程师团队都有独特的资格进行 建议的工作。